Botanix Pharmaceuticals Ltd (ASX:BOT) has crossed a major milestone by completing the Phase 1 safety, tolerability and pharmacokinetics clinical study of BTX 1503 for acne.
BTX 1503 is a topical treatment for moderate to severe acne, which utilises synthetic cannabidiol as the active ingredient, together with Botanix’s proprietary Permetrex™ drug delivery technology.
Top line data demonstrates that BTX 1503 has an excellent safety profile, with little to no skin irritation, and no severe adverse events were recorded.
The study also suggests that the Permetrex™ delivery technology ensures majority of the BTX 1503 drug stays in the target skin layers, with only small amounts of drug delivered into systemic circulation.
The delivery performance of Permetrex™ is a key consideration to allow targeting of the relevant organs in the skin, while avoiding excess drug being deposited directly into the blood stream.
Based on the data from this study, Botanix will now accelerate BTX 1503 into a follow up acne patient pilot study, which subject to ethics approval, will commence this quarter.
The planned acne patient study will be the first anywhere in the world to utilize synthetic cannabidiol as the active drug for the treatment of skin disease.
Botanix recently raised $7.4 million via the placement of shares at $0.055 each, to be used to accelerate product development.